Federal overdose report written by industry insider

Five years ago, Mike Blake walked into his daughter?s bedroom and found his wife lying on the floor, dead from an overdose of methadone and Xanax.

The 39-year-old mother of two from Indianapolis had just started taking methadone. A doctor had prescribed it for her back pain, Mike Blake said.

?My little girl was only 2 years old when that happened,? Blake said in a recent interview with the Gazette. ?She doesn?t have a mother now.?

Around the same time, newspapers and television stations around the country started reporting on overdose victims who took methadone, like Pam Blake.

In 2003, the Bush administration responded to these deaths by calling together the top experts on drug overdoses ? doctors, researchers, and medical examiners ? as well as representatives from the federal Drug Enforcement Administration, Food and Drug Administration, and the Substance Abuse and Mental Health Services Administration.

The man hired to research and write the report based on the conference, as well as a background paper for conference participants, was Stewart B. Leavitt, an addiction specialist whose work is funded by the makers of methadone.

Leavitt is editor of two Web sites that are supported entirely by one of the largest methadone manufacturers, Tyco/Mallinckrodt. Leavitt owns the for-profit company that publishes Pain Treatment Topix and he is editor of Addiction Treatment Forum, a Web site that advocates the use of methadone to treat addiction.

Leavitt said he raised the issue of a potential conflict of interest with Bush administration officials before he took the job. They saw no problem with hiring someone paid by a methadone company to write the report about a conference on methadone deaths, he said.

?They took a look at my work on Addiction Treatment Forum and realized we always took a balanced approach based on the evidence,? he said in a telephone interview.

A SAMHSA official said Leavitt was hired by a contractor and not directly by them. He saw no problem with the arrangement, however.

?We do not direct our contractors who to hire,? said Robert Lubran, director of the Division of Pharmacologic Therapies at SAMHSA. ?We might have made a recommendation.?

Mike Blake questions how someone so closely tied to the makers of methadone could be entrusted with such important work.

?Some of this stuff is just so pathetic,? he said. ?When they?re trying to figure out the real answers to things, they go about it the wrong way.?

?What the hell are you doing??

Bruce Goldberger was one of the first to sound the alarm about the increasing number of deaths involving methadone. He is director of the Forensic Toxicology Laboratory at the University of Florida.

In October 2002, Goldberger issued a press release about methadone deaths in his state. Within days, he received a phone call from an official at SAMHSA, he said.

The caller did not express concern about the overdose deaths, Goldberger said. Instead, he worried that the publicity could damage methadone-treatment facilities, which the agency regulates.

?He asked, ?What the hell are you doing? Do you have any idea how this will affect what we do??? Goldberger said.

But the story about overdose deaths was starting to get out. National and local media focused on what was seen as the most likely culprit ? drug treatment programs, known as methadone clinics. The clinics allowed some patients to leave with ?take-home? doses of liquid methadone so they don?t have to return every day. Some of those doses could be sold on the street.

In May 2003, the federal government gathered experts like Goldberger and Leavitt for a conference on ?methadone-associated mortality.?

Conference participants concluded that most overdose deaths were caused by methadone pain pills, not liquid methadone from drug treatment clinics, according to the report written by Leavitt.

That conclusion was reflected in the media release SAMHSA sent to news outlets after the conference: ?Methadone deaths not linked to misuse of methadone from treatment centers.?

?Methadone continues to be a safe, effective treatment for addiction to heroin or prescription painkillers,? said Westley Clark, director of the Center for Substance Abuse Treatment at SAMHSA, in the media release. ?While deaths involving methadone increased, experiences in several states show that addiction treatment programs are not the culprits.?

Little progress made

Experts at the conference came up with several recommendations to reduce methadone deaths. Three years later, little progress has been made to meet those goals, Goldberger and Leavitt said.

The report recommended that the federal government create a system to track drug overdose deaths as they happen, but there is no nationwide tracking effort today. The Drug Enforcement Agency has started a pilot program in three cities and four states, including West Virginia, called the Drug Related Death Reporting System.

Also, the report calls for a uniform definition of a methadone-related death and standards that toxicologists could use in testing. The new standards still are being developed, Lubran said.

The report also calls for more education of physicians and patients about the dangers of methadone. Leavitt says his newest Web site, Pain Treatment Topix, publishes information for doctors about safely prescribing methadone, such as one paper on dangerous drug interactions.

?They tell us that paper has saved lives,? Leavitt said.

A drug interaction may have killed Pam Blake, said her husband, Mike.

Years ago, she was in a car wreck that left her with disabling injuries to her back and brain stem.

Her back ?never healed right,? Mike Blake said. ?The doctor said maybe they could fix it.?

She had two back surgeries in one year, and then went to a pain management clinic.

?This was a woman who had a contusion on her brain stem. Her memory was bad,? he said. ?The doctor sent her home with 50 methadone pills and some Xanax.?

Xanax is a benzodiazepine, a type of drug that increases the risk of overdose when combined with opioids such as methadone.

She took the methadone for three days.

?She kept asking me and my stepson and my mother-in-law, ?Can you remember if I took my medication??? Blake said.

On June 19, 2001, ?I was with her right up until we went to bed that night,? he said. ?There was nothing unusual in her behavior.

?For some reason I got up in the middle of the night ...?

His wife had gone into their daughter?s room. She was already dead.

?I tried to give her CPR before they got there,? Blake said. ?We called an ambulance. They tried to resuscitate her with an electric defibrillator.

?It just happened so fast.?

He thinks his wife accidentally took more methadone than she was supposed to.

?There were still a whole lot of pills left,? he said. ?She might have taken a couple too many.

?I would like to see people not be able to get a whole bottle at one time ... There?s got to be a different way in pain management of dealing with this.?

To contact staff writers Scott Finn and Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189.